Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001003561
Ethics application status
Approved
Date submitted
15/09/2015
Date registered
25/09/2015
Date last updated
4/02/2021
Date data sharing statement initially provided
4/02/2021
Date results information initially provided
4/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Pain Course: A Replication and examination of the cost-effectiveness of an internet-delivered chronic pain management program.
Scientific title
A randomised controlled trial replicating the efficacy, and exploring the cost-effectiveness, of an internet-delivered Cognitive Behaviour Therapy (iCBT) program for adults with chronic pain on emotional and pain-related outcomes
Secondary ID [1] 287447 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 296165 0
Depression 296166 0
Anxiety 296167 0
Condition category
Condition code
Anaesthesiology 296446 296446 0 0
Pain management
Mental Health 296447 296447 0 0
Depression
Mental Health 296448 296448 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, the Pain Course, is an internet-delivered pain management program, which consists of:

(a) 5 online lessons provided over 8 weeks.
(b) A homework summary with assignments for each lesson
(c) Additional written resources that can be downloaded and which include information about other important skills, such as assertiveness and communication skills and techniques for managing sleep difficulties.
(d) Case Stories based on previous participants, which they can follow throughout the Course.
(e) Optional weekly contact with a Psychologist via secure email or telephone.

Participants will be encouraged to complete a lesson every 10 days and to read through a summary of the lesson and complete some basic homework in the following 10 days. Participants will have the option of contacting a Psychologist by phone or email each week for support with working through the course; each eCentreClinic Psychologist receives 1 hour or more of weekly supervision from another eCentreClinic Psychologist in which all of their participants are reviewed; as per best-practice guidelines and eCentreClinic Policy.

The Pain Course is based on cognitive behaviour therapy (CBT) principles and teaches evidence-based skills for managing pain, disability, anxiety and depression. Each lesson takes between 10 and 20 minutes to complete and it is suggested that participants read each lesson at least twice and spend approximately 3 hours, across the week, practicing the skills taught. Telephone calls will be limited to approximately 10 minutes per week; however, more time will be provided where clinically indicated. Adherence (e.g., logins, lesson completion, lesson views, time spent on course) will be monitored via the eCentreClinic software, which is used to provide the Pain Course.
Intervention code [1] 292818 0
Behaviour
Intervention code [2] 292819 0
Treatment: Other
Comparator / control treatment
A waitlist control group who begin the treatment immediately after the treatment groups complete the Course.
Control group
Active

Outcomes
Primary outcome [1] 296080 0
Pain Disability Index (PDI), a measure of how functioning is impacted by chronic pain.
Timepoint [1] 296080 0
Application, pre-treatment, post-treatment and 3 month post-treatment.
Primary outcome [2] 296081 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [2] 296081 0
Application, pre-treatment, post-treatment and 3 month post-treatment.
Primary outcome [3] 296082 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [3] 296082 0
Application, pre-treatment, post-treatment and 3 month post-treatment.
Secondary outcome [1] 317448 0
Wisconsin Brief Pain Questionnaire (WBPQ), which is a general measure of the nature of participants pain including location, severity and duration.
Timepoint [1] 317448 0
Application, pre-treatment, post-treatment and 3 month post-treatment.
Secondary outcome [2] 317450 0
EQ-5D-5L, which measures health outcome, and is used for cost-effectiveness analysis.
Timepoint [2] 317450 0
Application, pre-treatment, post-treatment and 3 month post-treatment.
Secondary outcome [3] 317451 0
Service use questionnaire, measures health service utilisation
Timepoint [3] 317451 0
Application, pre-treatment, post-treatment and 3 month post-treatment.

Eligibility
Key inclusion criteria
(a) Has experienced Chronic Pain (i.e. Pain > 6 months), which is still present at the time of participation.
(b) Australian resident
(c) Has had their pain assessed by their GP or medical specialist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Severe depression (i.e., indicated by a score > 22 on the PHQ-9)
(b) Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9)
(c) Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/09/2015
Actual
17/02/2016
Date of last participant enrolment
Anticipated
Actual
27/09/2016
Date of last data collection
Anticipated
Actual
27/04/2017
Sample size
Target
500
Accrual to date
Final
659
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292054 0
Self funded/Unfunded
Name [1] 292054 0
Country [1] 292054 0
Primary sponsor type
University
Name
eCentreClinic, Department of Psychology, Macquarie University
Address
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 290727 0
None
Name [1] 290727 0
Address [1] 290727 0
Country [1] 290727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293515 0
Macquarie University, Human Research Ethics Committee
Ethics committee address [1] 293515 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, NSW, 2109.
Ethics committee country [1] 293515 0
Australia
Date submitted for ethics approval [1] 293515 0
Approval date [1] 293515 0
15/09/2015
Ethics approval number [1] 293515 0
5201500692

Summary
Brief summary
The purpose of this proposed project is to replicate the efficacy of, and assess the cost-effectiveness, an established internet-delivered self-management program, the Pain Course, for chronic pain, when administered with optional clinician guidance versus a waitlist control. Participants in this research trial will be randomly allocated to receive the Course with optional telephone guidance from a clinician, or to a delayed-treatment control group.

Hypotheses:

1. The Pain Course will result in statistically and clinically significant improvements in symptoms of disability, anxiety and depression from pre-treatment to post-treatment compared to the treatment-as-usual Waitlist Control Group.

2. The Pain Course will be more cost-effective at common willingness-to-pay thresholds compared with treatment as usual.

3. Observed clinical improvements in symptoms of disability, anxiety and depression will be maintained at 3-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60218 0
Dr Blake Dear
Address 60218 0
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
Country 60218 0
Australia
Phone 60218 0
61 2 9850 9979
Fax 60218 0
Email 60218 0
[email protected]
Contact person for public queries
Name 60219 0
Dr Blake Dear
Address 60219 0
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
Country 60219 0
Australia
Phone 60219 0
61 2 9850 9979
Fax 60219 0
Email 60219 0
[email protected]
Contact person for scientific queries
Name 60220 0
Dr Blake Dear
Address 60220 0
eCentreClinic, Department of Psychology, Macquarie University, NSW, 2109.
Country 60220 0
Australia
Phone 60220 0
61 2 9850 9979
Fax 60220 0
Email 60220 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
When will data be available (start and end dates)?
Data will be made after any original reports have been published. There will be no end date to the availability.
Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
How or where can data be obtained?
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the chief investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Pain Course: A randomised controlled trial and economic evaluation of an internet-delivered pain management program.2022https://dx.doi.org/10.1097/j.pain.0000000000002507
N.B. These documents automatically identified may not have been verified by the study sponsor.